Reagent Container Pack

ABSTRACT

A reagent container pack for storing, preserving, and automatically unsealing and resealing a plurality of reagent containers in a reagent container pack on-board an automated clinical sample analyzer for analyzing analytes in a body fluid.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of U.S. patent applicationSer. No. 11/704,001 filed Feb. 8, 2007, the entirety which isincorporated by reference herein.

TECHNICAL FIELD OF THE INVENTION

The present invention relates to an automated clinical sample analyzerand more specifically to a reagent container pack for preserving,storing, and providing access to reagents for use by the automatedclinical sample analyzer.

BACKGROUND

Automatic clinical sample analyzers are common in hospitals and researchinstitutions for analyzing large quantities of samples. For example,environmental specimens, such as water, or patient specimens, such asblood, urine or other biological samples, can be tested using automatedsample analyzers to determine concentrations of contaminants oranalytes, for example.

Automated clinical sample analyzers have a variety of component systemsthat work in concert to manipulate patient samples. For example, anautomated clinical sample analyzer may have one or more reagentdispensing components, sample holder dispensing components, sample andreagent probes, washing stations, detecting mechanisms, and automatedarms, carousels, or conveyors for moving samples from one station toanother.

Automated clinical sample analyzers reduce time taken to perform assayson patient samples, improve output, and reduce human error andcontamination, thereby providing cost effective sample analysis.However, despite the automated functioning of such analyzers, operatorintervention is often required if a component malfunctions, or ifconsumables, such as reagents and sample holders, need replacing.Therefore, there is a need in the art for an automated clinical sampleanalyzer that reduces the need for operator intervention, therebyfurther improving efficiency, accuracy of testing, and throughput.

In satisfaction of the above-mentioned needs and others, the presentteachings relate to a system for providing a plurality of reagents in asingle reagent container pack that can be stored, preserved and readilyaccessed on-board an automated clinical sample analyzer for detecting ormeasuring one or more analytes in a body fluid.

SUMMARY OF THE INVENTION

In one aspect, the invention relates to an automated clinical sampleanalyzer for analyzing patient samples. In one embodiment of theinvention, the analyzer includes a reagent container pack for storing,preserving, and reducing evaporation of reagents, automaticallyunsealing and resealing reagent containers, and minimizing contaminationof reagent containers in the reagent pack by reducing operationintervention.

In one embodiment, the reagent container pack includes a housing or basefor holding a plurality of reagent containers. The base includes abottom, back wall and a vertical slot in the back wall extending fromthe bottom of the base along a portion of the back wall.

The reagent container pack has a cover. The cover fits over the top andpartially down the sides of the reagent container pack and istranslatable from an elevated position above the reagent containers to alower position in contact with the tops of the reagent containers. Thecover includes a horizontal slot near the cover surface extending fromone end to the other end of the cover. The cover further includes aplurality of holes in the cover surface in communication with hollowtubes projecting from the surface of the cover towards the tops of thereagent containers. Each of the hollow tubes has an opening into thehollow tube at each end. In one embodiment, the end of each hollow tubeon the reagent container side of the cover includes a tip.

The reagent container pack includes a lid which has a plurality ofthrough-holes corresponding in number to the hollow tubes of the cover.The lid is horizontally and reversibly slideable in the horizontal slotof the cover such that in one position the lid covers each of the hollowtubes and in another position the lid is uncovered from each of thehollow tubes of the cover.

An elongated tab is joined at one end to a fixed end of the cover at ahinge and extends downward along the back of the base toward the basebottom. The other end of the elongated tab is secured to and slideablymoveable in the vertical slot along the back side of the base. The innersurface of the elongated tab includes a horizontal tab projecting fromthe elongated tab towards the back of the base. When the upper portionof elongated tab, i.e., the portion above the horizontal tab, is pushedor pulled toward the back of the base, the lid transitions from arelaxed position in which the lid covers or “closes” the hollow tubes ofthe cover, to a biased position in which the hollow tubes of the coverare uncovered or “open”. When the cover is in the lower position overthe tops of the reagent containers, the transitioning of the lid fromclosed to open also uncovers the openings at the top of the reagentcontainers so that reagents can be accessed by, for example, a pipet.

When the push or pull on the elongated tab is released, the lid returnsto its relaxed position from the biased position. In the relaxedposition, the holes in the lid are not aligned with the hollow tubes ofthe cover and the holes in the cover surface thereby sealing theopenings of the reagent containers contained within the pack.

In another aspect, the invention relates to a method for storing,preserving, and automatically unsealing and resealing reagent containersin a reagent pack on-board an automated clinical sample analyzer by thecomponents of the reagent container pack described herein.

BRIEF DESCRIPTION OF THE FIGURES

These embodiments and other aspects of this invention will be readilyapparent from the detailed description below and the appended drawings,which are meant to illustrate and not to limit the invention, and inwhich:

FIG. 1A is a top view of the automated clinical sample analyzer systemaccording to an exemplary embodiment of the present invention.

FIG. 1B is a perspective view of the reagent station according to anexemplary embodiment of the present invention.

FIG. 2 is a perspective side-view of a reagent container pack includingsealed reagent containers and a cover in an elevated position accordingto an exemplary embodiment of the invention;

FIG. 3A is a cross-sectional view of the cover and lid of the reagentcontainer pack illustrated in FIG. 2 with the lid positioned over theopenings of the hollow tubes of the cover according to an exemplaryembodiment of the invention;

FIG. 3B is a cross-sectional view of the cover and lid illustrated inFIG. 3A with the openings of the hollow tubes uncovered by the lidaccording to an exemplary embodiment of the invention;

FIG. 4 is a perspective side-view of the reagent container packillustrated in FIG. 2 with the cover in the lower position with theseals of the reagent containers broken by the hollow tubes according toan exemplary embodiment of the invention;

FIG. 5 is a top perspective view of the sealing lid joined to theelongated tab according to one embodiment of the invention.

DESCRIPTION OF THE INVENTION

The present invention will be more completely understood through thefollowing description, which should be read in conjunction with theattached drawings. In this description, like numbers refer to similarelements within various embodiments of the present invention. Withinthis description, the claimed invention will be explained with respectto embodiments. The skilled artisan will readily appreciate that themethods and systems described herein are merely exemplary and thatvariations can be made without departing from the spirit and scope ofthe invention.

Embodiments of the invention relate to an automated clinical sampleanalyzer system for the automated analysis of patient samples. In oneembodiment, the analyzer may be used to analyze target biomolecules inbodily fluid samples, such as blood, plasma, serum, urine, orcerebrospinal fluid. The automated clinical sample analyzer systemaccording to the invention includes automation of immunochemical assaysfor the detection of a target biomolecule, for example, in a patientsample.

Embodiments of the present invention relate to an apparatus and methodfor preserving, storing and providing access to reagents in an automatedclinical sample analyzer for the detection and/or measurement of targetanalytes in a body fluid sample. The present invention is advantageousover prior art automated clinical sample analyzers at least byminimizing manual operator interface with reagents by automatingdisruption of reagent container seals and automating preservation,reducing evaporation, and minimizing contamination of reagents byautomated unsealing and resealing of the reagent containers withoutoperator intervention.

FIG. 1A is a top view of an automated clinical sample analyzer system 20according to an embodiment of the present invention. The illustratedautomated clinical sample analyzer system 20 contains one or morestations or modules for treatment and analysis of patient samplescontained in a vial. In one embodiment, the automated clinical sampleanalyzer system 20 includes at least the following: a vial loader 22, asample station (not shown) for adding a sample into a vial, a reagentstation 23 for holding reagents for use in a diagnostic assay, aplurality of pipettes 24 for providing wash and rinse fluid to the vialand for transporting reagents and samples into vials, a carousel 28 forreceiving vials from the vial loader and distributing the vials, amagnetic washing module 30, a luminometer 32, and a heater module 25 toincubate the sample vial.

FIG. 1B is a perspective view of the reagent station 23 according to anexemplary embodiment of the invention. The reagent station 23 includes areagent station housing 33, a bar code scanner 37 and one or morereagent container packs 200, wherein each reagent container pack has abar code 82. The reagent station housing 33 may be, for example, a bowlshaped container made of cast metal or plastic. One or more reagentcontainer packs 200 are stored within the reagent station bowl 33. Forexample, the reagent container pack 200 may be radially distributed fromthe center of the bowl-shaped housing 33. In one embodiment, the reagentcontainer pack 200 is inserted in a rotation carousel (not shown)positioned in the housing. The reagent station 23 may be temperatureand/or humidity controlled.

A reagent container pack 200 contains reagents in reagent containers 208which may be injected from the reagent container into a vial. In oneembodiment, the reagent container pack 200 is wedge or pie shaped suchthat a plurality of reagent container packs 200 may fit into the roundor bowl-shaped reagent station housing 33. For example, 5 to 35 reagentcontainer packs 200, or more specifically, 10, 20 or 30, or more reagentcontainer packs 200 may be placed into the reagent station housing 33 atone time, depending on the size of the reagent station housing 33.

With continued reference to FIG. 1B, the bar code scanner 37 permits auser to index and track the various reagent container packs 200. The barcode scanner 37 may read a bar code 82 placed on the side of the reagentcontainer pack 200 facing the bar code scanner 37. The bar code readingis sent to a computer processor that alerts the user of the automatedclinical sample analyzer system 20 of the location and content of thevarious reagent container packs 200. Additionally, the bar code scanner37 permits the user to electronically select various reagent containerpacks 200 for the desired analysis. The user may request requiredreagents and the bar code scanner 37 identifies the correspondingreagent container pack 200 containing those reagents. Thus, the bar codelabel 82 may be used to distinguish between different reagents in thereagent container packs 200 and may assist a user to determine thelocation of certain reagents within the reagent station 23.

FIG. 2 illustrates a reagent container pack 200 according to anexemplary embodiment of the invention. The reagent container pack 200includes a self-sealing lid 202, cover 204, elongated tab 218, and abase 206 for housing a plurality of reagent containers 208, e.g.,reagent tubes. The base 206 has a bottom 270. The bottom 270 may have aplurality of openings for engaging reagent containers 208. In oneembodiment, the base has a back side 230, front side 272, and two sidewalls 271 The cover 204 is vertically translatable relative to the base206 as shown by direction arrow “C”. The self-sealing lid 202 ispositioned in a horizontal slot 217 between the top portion 250 of thecover 204 and the bottom portion 251 of the cover. The top portion ofthe cover 250 has a plurality of holes 255 a, b, c, d. In oneembodiment, the top portion 250 of the cover 204 is optional and theself-sealing lid 202 is positioned on the surface of the cover portion250.

FIG. 2 illustrates four reagent containers, 208 a, 208 b, 208 c and 208d, housed within the reagent pack 200. However the invention is notlimited to the number of reagent containers illustrated and may havetwo, three, five or more reagent containers in a reagent container pack200. Reagent containers 208 hold a reagent, e.g., an antibody solution,buffer, or visualant, for example.

The reagent container pack 200 can have any convenient geometric shape,for example, a wedge-like shape, as illustrated in FIG. 1B, which allowsa plurality of such reagent “wedges” to be placed side-by-side in apie-like configuration on a carousel of an automated clinical analyzer,thereby permitting a wide variety of reagents types to be accessible forclinical analytical operations. Alternatively, the reagent containerpacks can be positioned in a linear or side-by-side array to provide abox-shaped configuration (not shown) in an automated clinical sampleanalyzer.

According to one embodiment of the invention, the reagent containers 208are removable and pre-filled with selected reagents. Each of the reagentcontainers 208 a, 208 b, 208 c, and 208 d, for example, include anopening 210 a, 210 b, 210 c, and 210 d, respectively, at the top of thereagent container. In one embodiment, the openings are pre-sealed with aseal 211 such as a piercable, adhesive-coated, metallic foil seal.

In one embodiment of the invention, each of the openings 210 a, 210 b,210 c, and 210 d of the reagent containers 208 a, 208 b, 208 c, and 208d, respectively, share a common cover 204. Referring to FIGS. 3A and 3B,the cover 204 includes a device for opening the seals 211 affixed to thetops 210 a, 210 b, 210 c, and 210 d of the reagent containers. Forexample, in one embodiment, the cover 204 includes a hollow piercingtube device 212 for piercing the seals 211 affixed over each of theopenings 210 a, 210 b, 210 c, and 210 d of the reagent containers.According to one embodiment, the hollow piercing tubes 212 extend fromthe top surface 207 of the cover 204 toward the openings 210 a, 210 b,210 c, and 210 d at the top of the reagent containers. According toanother embodiment, the hollow piercing tubes 212 extend downward fromthe top surface 252 of the bottom portion 251 of the cover 204 towardthe openings 210 a, 210 b, 210 c, and 210 d of the tops of the reagentcontainers 208.

Referring to FIG. 2, in one embodiment, each of the hollow piercingtubes 212 includes a tip 214. The tip 214 is capable of piercing theseals 211 on the reagent containers 210 when the cover 204 is pusheddown in the direction of Arrow “C” from an elevated position shown inFIG. 2 over the top of the reagent containers 208 a, 208 b, 208 c, and208 d to a lower position shown in FIG. 4 closer to the tops of thereagent containers 208 a, 208 b, 208 c, and 208 d.

Referring again to FIG. 2, in one embodiment according to the inventionthe cover 204 includes at least one snap lock mechanism 205 placed onthe side of the cover 204. In one embodiment, the snap lock mechanismmust be compressed inwardly to permit the cover 204 to transitiondownward toward the bottom of the base in the direction of arrow “C”from the elevated position illustrated in FIG. 2 to the lower positionillustrated in FIG. 4. In one embodiment, a snap lock mechanism 205 isplaced on each side of the cover 204.

After the seals 211 are pierced, the self-sealing lid 202 automaticallyreseals the reagent containers 208 a, 208 b, 208 c, and 208 d betweenintermittent reagent extractions without the need for externalmanipulation to effect re-closure.

Referring to FIG. 5, in one embodiment of the invention, the sealing lid202 is a planar, substantially rectangular, molded plastic memberincluding a plurality of through-openings 215 in the lid 202 whichcorrespond in number and distribution to the hollow piercing tubes 212in the cover 204 and to the openings 210 a, 210 b, 210 c, and 210 d atthe top of each reagent container 208 a, 208 b, 208 c, and 208 d,respectively. The plurality of openings 215 in the lid 202 alsocorrespond in number to the number of holes 255 in the top portion 250of the cover 204.

Referring again to FIG. 3A, the sealing lid 202 is reversibly slideablymoveable in a horizontal direction in the direction of arrows “A” and“B” in a horizontally oriented slot 217 positioned at the top of thecover 204. One end of the sealing lid 202 is joined to one end 219 of anelongated tab 218 by a hinge 220, for example, a plastic hinge that canbe molded in the elongated tab 218 or the sealing lid when theseelements are manufactured. For example, the plastic hinge 220 is part ofone integrally molded piece which includes the elongated tab 218, thesealing lid 202 and the hinge 220.

Referring again to FIG. 2, the elongated tab 218 extends downward towardthe bottom of the base 206 from the hinge 220. The other end 223 of theelongate tab 218 is secured and slideably moveable in a slot 222 locatedalong the back side 230 of the base 206 of the reagent container pack200. The slot 222 extends from the bottom of the base 206 along aportion of the back wall 230 toward the top of the base. Accordingly,downward pressure on the elongated tab 218, caused by, for example,downward pressure on the cover 204 as illustrated in FIG. 4, moves theend 223 of the elongated tab 218 downward in the slot 222. Referring toFIG. 4, this freedom of movement of the elongated tab 218 in a verticaldownward direction allows the elongated tab 218 to slide down in theslot 222 as the cover 204 is pushed onto the top of the reagentcontainers 208 to pierce the seals 211 with the hollow piercing tubes212.

Referring to FIG. 5, at a position about one third the distance from thesecured lower end 223 of the elongated tab 218, a horizontal tab 224projects horizontally from the inner face 221 of the elongated tab 218towards the back 230 of the base 206. Referring to FIG. 3A, when theupper two-thirds of the tab 218 that is the portion of the tab 218 abovehorizontal tab 224 is translated in the direction of arrow “A”, the lid202 moves in the same direction as arrow “A” allowing the holes 215 inthe sealing lid 202 to “open” by alignment of the holes 215 with thepiercing tubes 212 and the openings 250 at the top portion 250 of thecover 204.

Referring to FIG. 3B, spring bias is generated by the horizontal tab 224being forced against the back portion 230 of the base 206 and applyingpressure to the elongated tab 218 above the horizontal tab 224. When thepressure on the elongated tab 218 is released and the horizontal tab 224is no longer forced against the back portion 230, the elongated tab 218is biased back to its original relaxed position illustrated in FIG. 2Aand the sealing lid 202 closes the openings 255 in the cover 204 andcovers the openings of the piercing tubes 212 when it translates indirection of arrow “B” thereby returning to its original position. Inthe relaxed position, the holes of the sealing lid 215 are no longeraligned with the piercing tubes 212, the openings 250 of the cover 204and the openings 210 of the reagent containers 208. Consequently, theopenings 210 of the reagent containers 208 are “closed.”

The reagent wedges, i.e., reagent container packs, of the invention willsimultaneously support a relatively large number of assay types, e.g.,up to 30 or more, each requiring up to 2 or more reagents, withoutreduction of the on-board assay capacity of an automated clinicalchemical, biochemical, or immunoassay analyzer. The reagent containerpacks of the invention also provide the ability to store, preserve andaccess reagents on-board an immunoanalyzer, for example, for relativelyextended periods of time, without detectable degradation. The reagentpacks of the invention also permit reagents to be positively identifiedvia an attached bar code.

A rotating carousel described herein accommodates a plurality ofwedge-shaped reagent packs, each reagent pack capable of holding aplurality of different reagents in different compartments thereof. Thesepacks include instrument actuated covers with seal piercing devices aswell as bar codes which are accessible to the bar code reader. In oneembodiment, the entire carousel is housed within a refrigerator chambermaintained at about 4.degree. C.

By way of illustration, the reagents contained in the reagent containersare supplied in liquid form, and are used to generate a detectablesignal proportional or inversely proportional to the concentration ofanalyte in a specimen. Reagents are contained within reagent containerpacks in disposable reagent container packs, each bearing a plurality,e.g., up to two or more, different reagents. These reagent containerpacks protect their contents from the environment by virtue of theirinstrument actuated lids.

A plurality, e.g., up to 24 or more, of different reagent packs can besimultaneously mounted on the automated clinical scope analyzer, and theoperator may replace or supplement the supply of packs at any time. Aquantity of reagent may be consumed from one or more of the containersof a reagent pack for each test conducted by insertion of an aspirationby, for example, a pipette.

1. A reagent container pack comprising: a base for holding a pluralityof reagent containers, said base comprising a bottom, a back wall, and avertical slot extending from the bottom of said base along a portion ofthe back wall; a plurality of reagent containers each having a top sidecomprising an opening; a cover comprising a horizontal slot and aplurality of hollow tubes joined to said cover, said tubes comprising afirst end and a second end, each of said first and second endscomprising an opening, wherein said cover is translatable between anelevated position above the top sides of the plurality of reagentcontainers and a lowered position in which said cover is closer to thetop sides of the plurality of reagent containers than when in theelevated position; a lid comprising a plurality of holes, a free end,and a fixed end, wherein said lid is slideably moveable in saidhorizontal slot from a first position wherein said first hollow tube endis covered by said lid and a second position wherein said first hollowtube end is uncovered by said lid; an elongated tab joined at one end tothe fixed end of said lid and the other end of said elongated tabslideably moveable in the vertical slot of the base, said elongated tabcomprising an inner face and a horizontal tab extending horizontallyfrom said inner face toward said base back wall; wherein said elongatedtab is capable of transitioning from a first relaxed position to asecond biased position, whereby in said biased position of saidelongated tab, said lid transitions from said first position to saidsecond position; and wherein said other end of said elongated tab iscapable of moving from an upper position to a lower position in saidvertical slot when said cover is transitioned from an elevated positionto a lowered position. 2-3. (canceled)
 4. A reagent container packcomprising: a base for holding a plurality of reagent containers, saidbase comprising a bottom and a back wall; a cover comprising ahorizontal slot and a plurality of openings; a lid comprising aplurality of openings, a free end, and a fixed end, wherein said lid isslideably moveable in said horizontal slot from a first position whereinsaid openings in said lid do not align with the openings in said coverand a second position wherein said openings in said lid align with theopenings in said cover; an elongated tab joined at one end to the fixedend of said lid and the other end of said elongated tab secured to theback wall of the base, wherein said elongated tab is capable oftransitioning from a first relaxed position to a biased position,whereby in said biased position of said elongated tab, said lidtransitions from said first position to said second position.
 5. Thereagent pack of claim 4, further comprising a vertical slot extendingfrom the bottom of said base along a portion of the back wall of saidbase.
 6. The reagent pack of claim 5, wherein said other end of saidelongated tab is secured to said back wall of said base by placement inthe vertical slot and is slideably moveable in the vertical slot.
 7. Thereagent pack of claim 6, wherein the cover is vertically translatablerelative to the base and vertical translation of the cover permits theother end of said elongated tab to move from an upper position to alower position in said vertical slot when said cover is translatedvertically from an elevated position to a lowered position.
 8. Thereagent pack of claim 7, wherein depressing a snap lock mechanism on theside of the cover permits the cover to translate between the elevatedposition and the lowered position.
 9. The reagent pack of claim 4,further wherein said base holds a plurality of removable reagentcontainers.
 10. The reagent pack of claim 12, wherein each reagentcontainer comprises a seal sealing the opening of the reagent container.11. The reagent pack of claim 13, wherein translating the cover from anelevated position to a lowered position permits piercing of a sealsealing the opening of the reagent container by the hollow piercingtube.
 12. The reagent pack of claim 4, wherein each opening in the covercomprises a hollow piercing tube comprising a first end and a secondend, each of said first end and said second end comprising an opening.13. The reagent pack of claim 12, wherein said hollowing piercing tubecomprises a piercing tip.
 14. The reagent container pack of claim 4,wherein the base is wedge shaped.
 15. The reagent container pack ofclaim 4, wherein the base further comprises a front wall and two sidewalls.
 16. The reagent container pack of claim 4, wherein the elongatedtab is joined to the lid by a hinge.
 17. The reagent container pack ofclaim 16, wherein the elongated tab, hinge, and lid comprises oneintegrally molded piece.
 18. The reagent container pack of claim 4,wherein said lid slideably moves in said horizontal slot from said firstposition to said second position when a biasing force is applied to theelongated tab.
 19. The reagent container pack of claim 4, wherein saidlid slideably moves in said horizontal slot from said second position tosaid first position when said biasing force is released from theelongated tab.
 20. The reagent container pack of claim 4, wherein theelongated tab further comprises a horizontal tab capable of being biasedagainst the back side of the base.
 21. The reagent container pack ofclaim 4, wherein the cover has a top portion comprising a plurality ofholes and a bottom portion and the lid is positioned between the topportion and the bottom portion.
 22. A method for obtaining a reagentfrom the reagent container pack of claim 4 comprising: translating saidcover vertically relative to said base and piercing a seal on a reagentcontainer contained within the base; applying a biasing force to theelongated tab to transition said lid from said first relaxed position tosaid second biased position; inserting a pipette into a reagentcontainer via an opening in said lid; aspirating reagent into saidpipette; and releasing said biasing force on said elongated tab.